Jama for Medical Device Development

Jama Software helps medical device developers manage requirements, risk, testing and project volatility to ease the path to compliance. Free your teams from document-based requirements management, streamline processes and spend more time on innovation. Download the brochure for more information.

Jama Connect™

Gain Confidence in Your Compliance

Manage complex product requirements from idea through development, launch and iteration.

  • Align your development process to your regulatory strategy to achieve compliance for Class II and Class III medical devices
  • Use detailed impact analysis to inform decisions as requirements evolve
  • Manage design controls and build design history files (DHF) for both FDA CFR Part 820.30 and ISO 13485
  • Store everything in Jama Connect, so regulatory submissions and audit preparations become a straightforward process
 

Conduct reviews and approvals

Increase early stakeholder visibility and participation in reviews to generate approval-ready content for e-signature. When combined with your organization’s quality process, this helps achieve compliance with 21 CFR Part 11.

Verification and validation

Seamlessly manage traceability, including the test cases you use for verification and validation. When aligned to your organization’s quality process, you can also provide evidence to comply with FDA standards such as 21 CFR Part 820.

Maintain audit trails with reports

Customizable, real-time reporting and baselining allows you to track all changes to information within the system, including timestamps and associated users.

On Demand Webinar

Balancing Compliance & Innovation in the Medical Device Industry

Learn how Jama Software turns medical device development into a competitive advantage by improving the process to mitigate risk, reduce rework and ensure compliance.

Watch now

Jama Connect Risk Management Center

Mitigate Risk Early and Often

Analyzing risk is a critical part of medical device development. The Jama Connect Risk Management Center enables medical device developers to mitigate risk within the platform itself, in accordance with ISO 14971.

  • Participate in risk assessment such as Preliminary Hazard Analysis (PHA) and risk mitigation
  • Apply risk plan templates
  • Link verifications back to requirements
  • Export analyses for sign-off
  • Work with live data to ensure risks are properly mitigated

Download the datasheet

 

Medical Device Services

Streamline Your Development and Path to Compliance

Tightly aligned to ISO 13485:2016 & 21 CFR 820.30, Jama’s Medical Device Services facilitate the path to regulatory compliance and ensures teams get up and running quickly.

Out of the box framework for doing medical device development in Jama Connect.

User training tailored to your specific process.

Templates to produce required documentation for your DHF.

Consulting to tailor the solution to your unique needs.

See it in Action

This five-minute overview illustrates how to use Jama Connect to build a complex medical device that contains both hardware and software components. Activate your free, 30-day trial.

Try Jama Connect

Jama Analyze™

Gain Visibility and Enable Benchmarking

  • Trend and benchmark requirements and development data from Jama Connect & Jira
  • Understand how projects are progressing from definition through build and testing
  • Identify successful development patterns in iterations and processes
Jama Analyze Late Phase Team Metrics
Monitor defects and quality coverage as teams move into development.